Customer Program Quality Manager -  Tech Transfer and Quality Agreements

Do you have QA experience from manufacturing (Drug Substance/Drug Product/Finished Goods)? Are you interested in ensuring the right Quality level to our customers and keep them updated around the manufacturing of their products? Then you might be the key person we are looking for!

Come and join the Program Quality Management team for Manufacturing (PQM MFG) at FUJIFILM Diosynth Biotechnologies and play an important role in the relationship with our customers. With a fast-expanding site, our team is growing to support our increased number of customers. The PQM MFG team is accountable for the communication of all quality related topics affecting customer’s programs for production of Drug Substance, Drug Product and Finished goods. The communication is based on the responsibilities defined in Quality Agreement (QUAG).
 

About the Position

We work with various biopharma companies, which means each project we work on brings a unique set of challenges. As a PQM Tech Transfer lead, you are the link between our customers and our FDB team.

You will be involved in all quality related topics related to the Tech Transfer affecting customer’s programs and make sure customers are informed and involved to feel confidence in our collaboration. You will interact with highly skilled personnel to support your communication on complex activities. We continuously strive to identify opportunities to improve systems and practices and provide direction to our manufacturing group as well as technical development teams and our customers. You represent our company: our mission of advancing tomorrow’s medicine, our passion for collaborating with our partners for life, and our dedication to seeing every project through with the highest amount of integrity and impact.

Job Responsibilities

Your primary tasks:

• Be the primary point of contact regarding quality assurance when onboarding new customers
• Be the primary point of contact to customers regarding quality related topics to the Tech Transfer process
• Drive discussions with customers to establish new Quality Agreements as well as continuous revision of existing Quality Agreements
• Support Technical Transfers/Process Performance Qualifications manufacturing activities including representing quality assurance in the core team for the program
• Prepare and participate in customer visits in relation to Tech Transfer
• Establish, develop and maintain department documents: customer presentations, SOPS and participate in our internal Continuous Improvement activities
• Ad hoc tasks

About the Department/Team

The Program Quality Management (MFG) team consists of 8 highly skilled and dedicated team members with broad experience within pharmaceutical manufacturing. The team is an organization embedded in the Quality organization under Program Quality and provides quality support to production of engineering, clinical, PPQ and commercial batches in large scale Drug Substance manufacturing, filling of Drug Product and Assembly, Label and Pack.
 

About FUJIFILM Diosynth Biotechnologies and our Quality Department

FUJIFILM Diosynth Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our overall mission is to “Advancing Tomorrow’s Medicines” and we like to invite you to be part of that journey. Our Quality department at site Hillerød consists of approximately 350 employees divided into various QA and QC teams. In Quality we strive to help and support each other across teams not only to reach our goals but also to support a high level of collaboration and possibilities for personal development. The pillar in our Quality department is our employees – our success is only possible due to competent and dedicated colleagues, who wants to make a difference for Quality, our site, our customers, and patients all over the globe. As a leading CDMO company we, in Quality, are obligated to continuously improve our way of working creating a dynamic and inspiring environment with huge individual co-decision making due to our flat organizational structure.

The culture at FUJIFILM Denmark (FDBD) is key if you ask our employees and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.

Professional and Personal Qualifications

The candidate holds a master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar with interest and knowledge of GMP and quality systems with a minimum of 10 years of relevant QA experience. Experience with establishment and negotiation of Quality Agreements is preferred.

As a person you approach tasks and colleagues with openness and great energy. You possess a structured mindset and understand the importance of involving stakeholders in your daily work. You are self-starter and have a flexible, dynamic approach to work. You are service minded with excellent verbal and oral communication skills. Fluency in English is required as English is our corporate language.

At FDBD we put people first and we always look for candidates with the right combination of personality and skills. FUJIFILM Diosynth Biotechnologies will, as any other modern company, ask our employees for agility and flexibility from time to time but we always make sure to have a controlled work-life balance. We are many different nationalities and personalities at FDBD and for us to succeed we all need to focus on communication, take responsibility, organize, execute on various tasks, solve problems and display great interpersonal skills.

Application

Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.

In case you have any questions, please do not hesitate to contact Head of Program Quality Management, Manufacturing, Annelise Olsen +45 41945471.

The Company

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.